Table 3.
Summary of adverse events according to OLE baseline eGFR subgroup
| Subjets and events | REPRISE placebo subset | REPRISE tolvaptan subset | ||
|---|---|---|---|---|
| eGFRa | 15–24 | 25–29 | 15–24 | 25–29 |
| Subjects treated, n (%)b | 75 (100) | 73 (100) | 75 (100) | 73 (100) |
| Subject days of drug exposure, n | 39,992 | 41,439 | 43,025 | 44,948 |
| Subjects with AEs, n (%) | 68 (91) | 70 (96) | 69 (92) | 71 (97) |
| AEs, n | 565 | 647 | 504 | 576 |
| TEAEs, nc | 468 | 528 | 438 | 471 |
| Subjects with serious TEAEs, n (%) | 12 (16) | 16 (22) | 22 (29) | 16 (22) |
| Subjects with nonserious TEAEs, n (%) | 67 (89) | 70 (96) | 68 (91) | 71 (97) |
| Subjects with severe TEAEs, n (%) | 9 (12) | 11 (15) | 15 (20) | 10 (14) |
| Deaths, n (%) | 1 (1) | 0 | 0 | 1 (1) |
AE, adverse event; eGFR, estimated glomerular filtration rate; OLE, open-label extension; TEAE, treatment-emergent adverse event.
a
ml/min per 1.73 m2.
b
Percentages based on number of subjects treated.
c
TEAEs defined as AEs that started after trial drug treatment; or if AE was continuous from baseline and was serious or trial drug related, or resulted in death, discontinuation, interruption, or reduction of trial therapy. Multiple occurrences of TEAEs counted once per MedDRA preferred term.